What are the advantages of continuous monitoring, as opposed to episodic monitoring?
(1) Continuous monitoring and real time detection of microbes enables clean room management to take corrective measures in a timely manner if a microbe excursion happens; (2) continuous monitoring can provide trending data useful in locating the root cause a contamination problem; and, (3) continuous and real time environmental monitoring facilitates the implementation of FDA’s PAT initiative (Process Analytical Technology).